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Anti-tumor antibiotic

NMS-03597812 for AML

Phase 1

Recruiting

Research Sponsored by Nerviano Medical Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Confirmed diagnosis of refractory/relapsed (R/R) AML according to 2022 ELN recommendation

Must not have

Known active gastrointestinal disease or other malabsorption syndromes

Diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose to the date of death from any cause or start of a new anti-cancer therapy, whichever comes first (approximately 18 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the safety, how the drug moves through the body, and the initial impact on tumors of using NMS-03597812 alone in patients with Acute Myeloid Leuk

Who is the study for?

This trial is for adults with Acute Myeloid Leukemia (AML) that has come back or didn't respond to standard treatments. It's also looking at a subgroup of these patients who have specific genetic changes called TP53 mutations.

What is being tested?

The study tests NMS-03597812, a new potential treatment for AML. Initially, it's given alone to determine safety and dosage; later, it may be combined with another drug called venetoclax after further review.

What are the potential side effects?

Specific side effects of NMS-03597812 are not listed but generally could include typical reactions seen in cancer therapies such as nausea, fatigue, blood count changes, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most of my daily activities on my own.

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My AML has returned or is not responding to treatment as per 2022 guidelines.

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All side effects from my previous treatments, except for hair loss, are mild or gone.

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I have AML with TP53 mutation and standard treatments no longer work for me.

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I can swallow pills without any issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a digestive system disease that affects food absorption.

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I have been diagnosed with acute promyelocytic leukemia or BCR-ABL-positive leukemia.

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My leukemia has spread to my brain or spinal cord.

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I am currently receiving treatment for active graft versus host disease.

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I am taking medications that affect how my body processes drugs.

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I am taking medications that strongly or moderately inhibit P-gp.

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I have not had major surgery in the last 4 weeks.

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I had a stem cell transplant less than 3 months ago or have ongoing side effects from it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose to the date of death from any cause or start of a new anti-cancer therapy, whichever comes first (approximately 18 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose to the date of death from any cause or start of a new anti-cancer therapy, whichever comes first (approximately 18 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose to the date of death from any cause or start of a new anti-cancer therapy, whichever comes first (approximately 18 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase Ia (escalation) - Number of Participants with Adverse Events (AEs)

Phase Ib (expansion) - Complete Remission (CR) rate

Secondary study objectives

Phase Ia - Accumulation ratio (Rac) of NMS-0597812

Phase Ia - Complete remission (CR) rate

Phase Ia - Cumulative amount recovered unchanged in the urine (Ae) of NMS-03597812 (data permitting)

+17 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NMS-03597812Experimental Treatment1 Intervention

Dose escalation (Phase Ia): Administered orally once daily (28 consecutive days) in repeated 4-week cycles. Each cycle is 28 days. Expansion cohorts (Phase Ib, Cohorts A and B): The dose expansion may comprise up to a total of 2 single arms of NMS-03597812 as single agent: * Cohort A: in patients with TP53mt relapsed/refractory acute myeloid leukemia (R/R AML) prior unfit to intensive chemotherapy (IC) who have exhausted standard treatment options * Cohort B: in prior fit or unfit patients to IC with TP53wt R/R AML who have exhausted standard treatment options Backfill cohorts: Optional backfill cohorts may be opened at any time during the conduct of the trial to further evaluate the following items: NMS-03597812 dosing alone, pharmacokinetic (PK), drug-drug interactions, food effects, biomarkers and QTc for NMS-03597812 as single agent.

0 / 13Eligibility criteria met